BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT

    MDR report key: 18140412 · Received November 15, 2023

    Report

    Report Number
    9680794-2023-00886
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 18, 2023
    Report Date
    October 18, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    UDI-DI
    30801902125386
    PMA / PMN Number
    K160925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). ONE K-01351-051 STYLET: .015" DIA X 29" AND ONE MC-45552-003C COATED CATH 2-L: 5.5 FR X 21-21/32" 55CM COATED CATHETER WERE RETURNED. A VISUAL EXAMINATION OF THE STYLET REVEALED THE STYLET WIRES ARE SEPARATED FROM THE STYLET HOUSING AND THE T-PORT EXTENSION. USING CALIBRATED RULER, KINKS WERE OBSERVED APPROXIMATELY 8 3/4, 22 1/4, AND 28 INCHES FROM THE STYLET DISTAL TIP. A VISUAL EXAMINATION OF THE CATHETER REVEALED THE CATHETER WAS TRIMMED TO 46 CM WITH NO OTHER OBVIOUS DEFECTS OR ANOMALIES OBSERVED. THE OVERALL LENGTH OF THE RETURNED STYLET WIRES MEASURED APPROXIMATELY 30 1/8 INCHES, WHICH MEETS THE SPECIFICATIONS OF.015" X 29". NO PART OF THE ORIGINAL WIRES WERE OBSERVED TO BE MISSING. IT WAS REPORTED "THE TIP TRACKER STYLET SEPARATED FROM THE STEREO JACK CONNECTOR FOLLOWING UNSUCCESSFUL PICC PLACEMENT. WIRE IS NOTED TO HAVE DEFORMITY AND WAS VERY DIFFICULT TO REMOVE FROM THE PICC PRIOR TO SEPARATION". PHOTOGRAPHS WERE PROVIDED BY THE COMPLAINANT. PICTURE 1 SHOWS THE ECG WIRE AND THE COIL WIRE ARE MISSING FROM THE STYLET HOUSING AND T-PORT CONNECTOR. PICTURE 2 SHOWS A VIEW OF THE T-PORT CONNECTOR WITHOUT A STYLET. DURING FUNCTIONAL TESTING, THE RETURNED STYLET WAS THREADED THROUGH AND REMOVED FROM THE RETURNED CATHETER WITH NO ISSUES OBSERVED. A KNOWN GOOD STYLET WAS THREADED THROUGH AND REMOVED FROM THE RETURNED CATHETER WITH NO ISSUES OBSERVED. NO ISSUES WERE OBSERVED WITH THE RETURNED CATHETER. THE COIL WIRE HAS BEEN BROKEN AND IS NO LONGER IN THE HOUSING AND THE CORE WIRE WAS SOLDERED IN THE HOUSING AT ONE TIME BUT THE CORE WIRE IS NO LONGER IN THE HOUSING. THE POLYIMIDE TUBING HAS BEEN ABRADED FOR APPROXIMATELY 1 INCH STARTING AT APPROXIMATELY 2 1/2 INCHES FROM THE STYLET HOUSING. THE ABRASION RESULTS IN EXPOSING THE CORE WIRE AND COIL WIRE, BUT THEY REMAIN INTACT. THE ABRASION IS LOCATED WELL ABOVE THE LUER FITTINGS AND THAT PART OF THE STYLET WAS MOST LIKELY NOT IN THE CATHETER AT ANY TIME. THE ABRASION MOST LIKELY OCCURRED DURING ATTEMPTS TO REMOVE THE STYLET FROM THE CATHETER. THE WHITE POLYURETHANE STRAIN RELIEF IS SECURED TO THE HOUSING. THE RESULTS OF THE FUNCTIONAL INSPECTION SUGGESTS THE USER UNINTENTIONALLY SUBJECTED THE STYLET TO A FORCE WHICH DEFEATED THE STRAIN RELIEF WHERE THE STYLET EXITS THE STYLET HOUSING. A DEVICE HISTORY RECORD REVIEW PERFORMED ON THE STYLET DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE REPORT "WIRE IS NOTED TO HAVE DEFORMITY" WAS CONFIRMED BY THE EXISTENCE OF THE KINKS AND THE ABRASION OF THE STYLET. THE REPORT "TIP TRACKER STYLET SEPARATED FROM THE STEREO JACK CONNECTOR" WAS CONFIRMED BY VISUAL EVALUATION. A DEVICE HISTORY RECORD REVIEW PERFORMED ON THE STYLET DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE FINDINGS OF THIS INVESTIGATION SUGGESTS THE USER UNINTENTIONALLY SUBJECTED THE STYLET TO A FORCE WHICH DEFEATED THE STRAIN RELIEF WHERE THE STYLET EXITS THE STYLET HOUSING. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE TIP TRACKER STYLET SEPARATED FROM THE STEREOJACK CONNECTOR FOLLOWING UNSUCCESSFUL PICC PLACEMENT. WIRE IS NOTED TO HAVE A DEFORMITY AND WAS VERY DIFFICULT TO REMOVE FROM THE PICC PRIOR TO SEPARATION. ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING USE. NO MEDICAL INTERVENTION WAS NEEDED AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE TIP TRACKER STYLET SEPARATED FROM THE STEREOJACK CONNECTOR FOLLOWING UNSUCCESSFUL PICC PLACEMENT. WIRE IS NOTED TO HAVE A DEFORMITY AND WAS VERY DIFFICULT TO REMOVE FROM THE PICC PRIOR TO SEPARATION. ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING USE. NO MEDICAL INTERVENTION WAS NEEDED AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912374 ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT CATHETER INTRAVASCULAR THERAPE LJS ARROW INTERNATIONAL LLC 33F23G0522 30801902125386

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED| NOT REPORTED